Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Study Details
Study Description
Brief Summary
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.
Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.
Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fludarabine Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients |
Drug: Fludarabine
Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min
Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr
Population pharmacokinetics analysis
Comparative analysis of population pharmacokinetics in pediatric and adult patients
Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate
|
Outcome Measures
Primary Outcome Measures
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients [0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose]
Secondary Outcome Measures
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients [3 years]
- Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine [1, 3, 6 and 12 months after transplantation]
- Evaluation of therapy related toxicity, significant adverse reaction [for 4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Conditioning regimen including fludarabine
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Age: < 19 years old
-
Functional class: ECOG 0-2
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No loss of function of major organs. Criteria may be individualized.
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Heart: shortening fraction > 30%, ejection fraction > 45%.
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Liver: total bilirubin < 2 ⅹ upper limit of normal; ALT < 3 ⅹ upper limit of normal.
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Kidney: creatinine < 2 ⅹ normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
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No active viral or fungal infection
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Appropriate hematopoietic stem cell donor
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Informed consent from patients' parents
Exclusion Criteria:
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Pregnant or breast feeding
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Disease progression due to clinical test
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Psychiatric disease may interfere with clinical test
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Whether attending physician consider the patient inappropriate for study enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Daehangno, Jongno-gu | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
- Ministry of Food and Drug Safety, Korea
Investigators
- Principal Investigator: Hyoung Jin Kang, MD., PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUCH-SCT-1101